ClassName/CompanyApproval Dates and Comments

Antiacne Agent
Drospirenone/ Ethinyl Estradiol
The US FDA approved a new indication for this oral contraceptive (OC) in January 2007 to treat moderate acne vulgaris in women who desire an OC for birth control.

Clobetasol Propionate 0.05%
Olux-E™ Foam
Stiefel Laboratories
The US FDA approved this corticosteroid in January 2007 for the treatment of inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses (psoriasis and eczema) in patients over 12 years of age.

US FDA Advisory Committee Membership Eligibility

In March 2007, The US FDA announced new draft guidance that would implement a more stringent approach for considering potential conflicts of interest of its advisory committee members and for recommending eligibility for meeting participation. This new guidance (www.fda.gov/oc/advisory/waiver/coiguidedft.html) would reduce the likelihood that the process for recommending waivers would vary from meeting to meeting. In addition to a more streamlined approach for considering who may participate in meetings, the FDA would tighten its policy for considering eligibility for participation. Anyone who has disqualifying financial interests with a combined value exceeding $50,000 after applying certain exemptions, would generally not be considered for participation in the meeting, regardless of the need for his or her expertise. If the financial interests are <$50,000 after applying certain exemptions, the individual might be recommended to participate as a non-voting member. Only individuals with no potential conflicts would be eligible to fully participate in meetings as voting members. The FDA is accepting public comments on the proposal through May 20, 2007.

Drug News

HPV Infections
A study published in a recent issue of the JAMA*, suggested that about one in four US females between the ages of 14 and 59 years may have the sexually transmitted human papillomavirus (HPV) infection. Prevalence of any HPV infection was highest among females aged 20-24 years (44.8%); and overall HPV prevalence among females aged 14-24 years was 33.8%. However, the prevalence of HPV vaccine types 6 and 11 (low-risk types), and 16 and 18 (high-risk types) was relatively low (only 3.4% of female participants).
*Dunne EF, et al. JAMA 297(8):876-8 (2007 Feb 28).

Stress and Acne
The largest study ever conducted on acne and stress, recently published in Acta Dermato-Venerologica* reveals that teenagers who were under high levels of stress were 23% more likely to have increased acne severity. The study involved 94 secondary school students in Singapore with a mean age of 14.9 years. The students’ self-reported stress levels and acne severity were measured at two different times – just before mid-year exams and during summer break. Students reporting high stress were 23 percent more likely to have increased severity of acne papulopustulosa. Levels of stress were not linked to severity of acne comedonica.
*Yosipovitch G, et al. Acta Derm Venereol 87(2):135-9 (2007 Mar).